Valneva Seeks Approval To Expand IXCHIQ Chikungunya Vaccine Use To Adolescents In ...
Valneva SE submitted label extension applications to EMA and Health Canada for its chikungunya vaccine, IXCHIQ, to expand use to adolescents aged 12-17 in Europe and Canada. The company plans to submit data to the FDA this year for potential U.S. label extensions. IXCHIQ is currently approved for individuals 18 and older in the U.S., Europe, and Canada, with first sales anticipated in Q4 2024. Valneva expects marketing authorization in Brazil in H2 2024 and expanded partnership with CEPI for broader vaccine access in LMICs, supported by up to $41.3 million in additional funding.
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Valneva submitted label extension applications to EMA and Health Canada to expand IXCHIQ® use to adolescents aged 12-17, with 2-year antibody persistence data. The company plans to submit data to the FDA for U.S. label extensions and expects marketing authorization in Brazil in H2 2024. Valneva also expanded its partnership with CEPI for broader vaccine access in LMICs.
Valneva SE submitted label extension applications to EMA and Health Canada for its chikungunya vaccine, IXCHIQ, to expand use to adolescents aged 12-17 in Europe and Canada. The company plans to submit data to the FDA this year for potential U.S. extensions. IXCHIQ is currently approved for individuals 18 and older in the U.S., Europe, and Canada, with first sales anticipated in Q4 2024. Valneva expects marketing authorization in Brazil in H2 2024 and expanded partnership with CEPI for broader vaccine access in LMICs, supported by up to $41.3 million in funding.
Valneva SE submitted label extension applications to EMA and Health Canada for its chikungunya vaccine, IXCHIQ, to expand use to adolescents aged 12-17 in Europe and Canada. The company expects to submit data to the FDA this year for potential U.S. label extensions. IXCHIQ is the world's first licensed chikungunya vaccine, currently approved for individuals 18 and older, with first sales anticipated in Canada and Europe in Q4 2024. Valneva also aims to secure marketing authorization in Brazil in H2 2024 and expand vaccine access in Low Middle-Income Countries with CEPI funding.
Valneva SE submitted label extension applications to EMA and Health Canada for its chikungunya vaccine, IXCHIQ, to expand use to adolescents aged 12-17 in Europe and Canada. The company plans to submit data to the FDA this year for potential U.S. label extensions. IXCHIQ is currently approved for individuals 18 and older in the U.S., Europe, and Canada, with first sales anticipated in Q4 2024. Valneva expects marketing authorization in Brazil in H2 2024 and expanded partnership with CEPI for broader vaccine access in LMICs, supported by up to $41.3 million in additional funding.
Valneva SE submits label extension applications to EMA and Health Canada to expand IXCHIQ® chikungunya vaccine use to adolescents aged 12-17, with 2-year antibody persistence data included. The vaccine is currently approved for individuals 18 and older in the U.S., Europe, and Canada, with first sales anticipated in Q4 2024. Valneva also expects marketing authorization in Brazil and expanded access in Low Middle-Income Countries with CEPI funding.